Irritable Bowel Syndrome Characterized by ConstipationNCT02732743

Food Supplement Physiomanna® Baby in Pediatric Patients

A study testing Physiomanna® Baby in people with Irritable Bowel Syndrome Characterized by Constipation, run by Iuppa Industriale Srl at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective is to assess the efficacy and safety of the Food Supplement Physiomanna® Baby in pediatric patients with a history of functional constipation The secondary objective of the trial is to evaluate the adherence to product's administration in the enrolled children. Read more about this study

Who is it for?: Ages 1 week to 8 years
Conditions the study is for: Irritable Bowel Syndrome Characterized by Constipation
What is being tested?: Physiomanna® Baby
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteRomania
Study dates: Feb 2016to Apr 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 week to 8 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female outpatients between the ages of 0 to 8 years;
Functional constipation according to ROME III criteria (Annex 2);
Two or fewer SBM during the previous week; SBM is defined as BM not preceded after a 24 h administration with a laxative or enema;
To be otherwise in good health, as judged by a physical examination;
Mentally competent parent or tutor to sign an informed consent

Who cannot join

Known history of organic cause for the constipation;
Congenital malformations that produce constipation (Hirschsprung's disease, imperforate anus, children with cerebral palsy or other neurologic abnormalities, or systemic diseases);
Fecal Occult Blood Test (FOBT) positive in the 4 previous weeks;
Fecal impaction at baseline, or during the trial period, as indicated by the physical examination;
Known or suspected perforation or obstruction other than fecal impaction;
History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy;

Show all 13Show fewer

Use of concomitant medications that cause constipation in the previous 3 months;
Concomitant use of herbs and other dietary supplements, such as: stimulant laxative herbs and/or potassium depleting herbs;
Concomitant use of cardiac glycosides(e.g. Digoxin);
Patients who, according to the investigator, should not be included in the study for any reason, including the parent's inability to follow the study procedures;
Patients with known allergy to Fraxinus Manna, mannitole, fennel, lemon balm or chamomile;
Patients with clinically significant elevations of TSH or abnormal plasma electrolytes in the 4 previous weeks;
Patients who, within the past 30 days have participated in an investigational clinical study;

Trial locations and contacts

1 site in 1 country.

Romania1 site

Opera Contract Research Organization SRL
Timișoara, Timiș County, 300209

Other trials in Romania

About this study

Official title: An Open Label, Non-comparative Pilot Study to Assess the Efficacy and Safety of the Food Supplement Physiomanna® Baby in Pediatric Patients With a History of Functional Constipation

The primary objective is to assess the efficacy and safety of the Food Supplement Physiomanna® Baby in pediatric patients with a history of functional constipation

The secondary objective of the trial is to evaluate the adherence to product's administration in the enrolled children.

Read the detailed description

This is an interventional, non-controlled, multicenter trial with a prospective design in one cohort of patients. This clinical investigation will be performed in 3 centers in Romania.

The tested hypothesis is that Physiomanna® Baby administration for 3 weeks, increases the SBM to be more than 2 times per week.

Conditions: Irritable Bowel Syndrome Characterized by Constipation
Being tested: Physiomanna® Baby
Keywords: childhod constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Physiomanna® BabyDietary supplement
Dosage 1g/kg body, 2 cycles (if applicable)

Study groups in NCT02732743
Study group	Role	What they receive
Food Supplement Physiomanna® Baby	Other	Dosage: 1g/kg body Receives: Dietary Supplement: Physiomanna® Baby

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Spontaneous Bowel Movements (SBM) per week
Measured: 2-3 weeks

Secondary outcomes (1)

Safety: Adverse Events (AE) check; Investigator and Patient Global Assessment
Measured: 2-3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2016Apr 2016

First posted11 Apr 2016 (estimated)
Study startFeb 2016
Primary completionApr 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Irritable Bowel Syndrome Characterized by ConstipationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02732743
Sponsor's protocol ID: IU01/016
Status last verified: Mar 2017
First submitted: 31 Mar 2016
Last updated: 24 Oct 2019
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

Tabbers MM, Boluyt N, Berger MY, Benninga MA. Clinical practice : diagnosis and treatment of functional constipation. Eur J Pediatr. 2011 Aug;170(8):955-63. doi: 10.1007/s00431-011-1515-5. Epub 2011 Jun 24.
PubMed 21701812
Tabbers MM, Boluyt N, Berger MY, Benninga MA. Nonpharmacologic treatments for childhood constipation: systematic review. Pediatrics. 2011 Oct;128(4):753-61. doi: 10.1542/peds.2011-0179. Epub 2011 Sep 26.
PubMed 21949142
Loening-Baucke V, Miele E, Staiano A. Fiber (glucomannan) is beneficial in the treatment of childhood constipation. Pediatrics. 2004 Mar;113(3 Pt 1):e259-64. doi: 10.1542/peds.113.3.e259.
PubMed 14993586
Livesey G. Health potential of polyols as sugar replacers, with emphasis on low glycaemic properties. Nutr Res Rev. 2003 Dec;16(2):163-91. doi: 10.1079/NRR200371.
PubMed 19087388
Caligiani A, Tonelli L, Palla G, Marseglia A, Rossi D, Bruni R. Looking beyond sugars: phytochemical profiling and standardization of manna exudates from Sicilian Fraxinus excelsior L. Fitoterapia. 2013 Oct;90:65-72. doi: 10.1016/j.fitote.2013.07.002. Epub 2013 Jul 10.
PubMed 23850543
Kountouras J, Magoula I, Tsapas G, Liatsis I. The effect of mannitol and secretin on the biliary transport of urate in humans. Hepatology. 1996 Feb;23(2):229-33. doi: 10.1053/jhep.1996.v23.pm0008591845.
PubMed 8591845
Taylor SN, Basile LA, Ebeling M, Wagner CL. Intestinal permeability in preterm infants by feeding type: mother's milk versus formula. Breastfeed Med. 2009 Mar;4(1):11-5. doi: 10.1089/bfm.2008.0114.
PubMed 19196035

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Irritable Bowel Syndrome Characterized by Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Non-comparative Pilot Study to Assess the Efficacy and Safety of the Food Supplement Physiomanna® Baby in Pediatric Patients With a History of Functional Constipation
ClinicalTrials.gov ID: NCT02732743
Acronym / sponsor ID: IU01/016
Conditions: Irritable Bowel Syndrome Characterized by Constipation
Keywords: childhod constipation
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Iuppa Industriale SrlUniversity, hospital or other
Collaborators: Opera CRO, a TIGERMED Group Company
Study start: Feb 2016
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 11 Apr 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective is to assess the efficacy and safety of the Food Supplement Physiomanna® Baby in pediatric patients with a history of functional constipation

The secondary objective of the trial is to evaluate the adherence to product's administration in the enrolled children.

Detailed description

This is an interventional, non-controlled, multicenter trial with a prospective design in one cohort of patients. This clinical investigation will be performed in 3 centers in Romania.

The tested hypothesis is that Physiomanna® Baby administration for 3 weeks, increases the SBM to be more than 2 times per week.

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Food Supplement Physiomanna® Baby	Other	Dietary Supplement: Physiomanna® BabyDosage: 1g/kg body

Who may qualify

Ages: 1 week to 8 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Male or female outpatients between the ages of 0 to 8 years;
Functional constipation according to ROME III criteria (Annex 2);
Two or fewer SBM during the previous week; SBM is defined as BM not preceded after a 24 h administration with a laxative or enema;
To be otherwise in good health, as judged by a physical examination;
Mentally competent parent or tutor to sign an informed consent

Key exclusion criteria (13 listed)

Known history of organic cause for the constipation;
Congenital malformations that produce constipation (Hirschsprung's disease, imperforate anus, children with cerebral palsy or other neurologic abnormalities, or systemic diseases);
Fecal Occult Blood Test (FOBT) positive in the 4 previous weeks;
Fecal impaction at baseline, or during the trial period, as indicated by the physical examination;
Known or suspected perforation or obstruction other than fecal impaction;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Physiomanna® BabyDosage 1g/kg body, 2 cycles (if applicable)	Dietary supplement	Food Supplement Physiomanna® Baby

Primary outcome

Number of Spontaneous Bowel Movements (SBM) per week
Time frame: 2-3 weeks

1 secondary outcome

Safety: Adverse Events (AE) check; Investigator and Patient Global Assessment
Time frame: 2-3 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2019.
Background: PubMed 21701812Tabbers MM, Boluyt N, Berger MY, Benninga MA. Clinical practice : diagnosis and treatment of functional constipation. Eur J Pediatr. 2011 Aug;170(8):955-63. doi: 10.1007/s00431-011-1515-5. Epub 2011 Jun 24.
Background: PubMed 21949142Tabbers MM, Boluyt N, Berger MY, Benninga MA. Nonpharmacologic treatments for childhood constipation: systematic review. Pediatrics. 2011 Oct;128(4):753-61. doi: 10.1542/peds.2011-0179. Epub 2011 Sep 26.
Background: PubMed 14993586Loening-Baucke V, Miele E, Staiano A. Fiber (glucomannan) is beneficial in the treatment of childhood constipation. Pediatrics. 2004 Mar;113(3 Pt 1):e259-64. doi: 10.1542/peds.113.3.e259.
Background: PubMed 19087388Livesey G. Health potential of polyols as sugar replacers, with emphasis on low glycaemic properties. Nutr Res Rev. 2003 Dec;16(2):163-91. doi: 10.1079/NRR200371.
Background: PubMed 23850543Caligiani A, Tonelli L, Palla G, Marseglia A, Rossi D, Bruni R. Looking beyond sugars: phytochemical profiling and standardization of manna exudates from Sicilian Fraxinus excelsior L. Fitoterapia. 2013 Oct;90:65-72. doi: 10.1016/j.fitote.2013.07.002. Epub 2013 Jul 10.
Background: PubMed 8591845Kountouras J, Magoula I, Tsapas G, Liatsis I. The effect of mannitol and secretin on the biliary transport of urate in humans. Hepatology. 1996 Feb;23(2):229-33. doi: 10.1053/jhep.1996.v23.pm0008591845.
Background: PubMed 19196035Taylor SN, Basile LA, Ebeling M, Wagner CL. Intestinal permeability in preterm infants by feeding type: mother's milk versus formula. Breastfeed Med. 2009 Mar;4(1):11-5. doi: 10.1089/bfm.2008.0114.
Individual participant dataSharing planned: No

Related trials for Irritable Bowel Syndrome Characterized by Constipation

Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Barattini Dionisio, MD study director

Opera CRO

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Physiomanna® Baby in people with Irritable Bowel Syndrome Characterized by Constipation, run by Iuppa Industriale Srl at 1 site in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Spontaneous Bowel Movements (SBM) per week (time frame: 2-3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02732743, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2019.